GEI: Electrosurgical, Cutting & Coagulation & Accessories

510(k) review time for GEI

Across 473 510(k) clearances under GEI decided from 2018-01-01 to 2026-10-06, the median was 117 days from FDA receipt to decision. Half took between 59 and 220 days, and 80% were decided within 242 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, GEI, decisions 2018-01-01 to 2026-10-06 (n = 473)

Fastest	10
25th percentile	59
Median	117
75th percentile	220
80th percentile	242
90th percentile	301
Slowest	651

Median days by decision year, GEI (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.

Year	Median days	n
2018	93	47
2019	93	48
2020	105	59
2021	146	46
2022	150	55
2023	104	65
2024	125	59
2025	113	52
2026 (to 10-06, partial)	185	42

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

GEI in the public FDA record

Records naming GEI, from openFDA (snapshot of 2026-09-15)

510(k) clearances, all years	2,315
Device recalls	644
Establishment listings	4,802
GUDID device identifiers	51,276

Counts of records, not of devices or events. Adverse event reports for GEI are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite GEI

2 FDA recognized consensus standards cite GEI, 1 of them recognized only in part, among them IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

• 6-389 IEC 60601-2-2 Edition 6.0 2017-03 (partial recognition) — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• 6-521 IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

Related product codes

• NEY System, Ablation, Microwave And Accessories
• NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
• OAB Low Energy Direct Current Thermal Ablation System
• OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
• PBX Massager, Vacuum, Radio Frequency Induced Heat
• GEX Powered Laser Surgical Instrument